Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Acute Effects of TCIG vs ECIG in PLWH

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04568395
Recruitment Status : Recruiting
First Posted : September 29, 2020
Last Update Posted : October 8, 2020
Sponsor:
Collaborator:
Tobacco Related Disease Research Program
Information provided by (Responsible Party):
Holly R Middlekauff, University of California, Los Angeles

Brief Summary:
Randomized controlled trial of acute use of electronic cigarette or tobacco cigarette on parameters of ventricular repolarization and inflammation/oxidative stress.

Condition or disease Intervention/treatment Phase
E Cigarette Use Vaping Smoking Tobacco Smoking Nicotine Use Disorder Qt Interval, Variation in HIV I Infection Oxidative Stress Inflammation Other: TCIG Other: ECIG Other: sham control Not Applicable

Detailed Description:
On separate days, participants will undergo 3 different exposures: an acute e-cigarette exposure, an acute tobacco cigarette exposure, and a sham (empty e-cigarette) control . Before and after the acute exposure, participants will have blood drawn for inflammation/oxidative stress markers and undergo a 5-minute ECG recording.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Crossover with 1 week washout
Masking: None (Open Label)
Masking Description: single (outcomes assessor) code
Primary Purpose: Basic Science
Official Title: Acute Impact of Switching From Tobacco Cigarettes to E-Cigarettes in People Living With HIV
Actual Study Start Date : October 1, 2020
Estimated Primary Completion Date : October 31, 2023
Estimated Study Completion Date : October 31, 2024

Arm Intervention/treatment
Experimental: PLWH smoker
PLWH who smoke will undergo 3 interventions : acute TCIG use, acute ECIG use and acute sham control
Other: TCIG
Use a TCIG

Other: ECIG
Use an ECIG

Other: sham control
Use a sham control (empty ECIG)




Primary Outcome Measures :
  1. Tpe [ Time Frame: Change in Tpe 5 minutes after cigarette use ]
    interval indicative of ventricular repolarization measured on ECG

  2. Tpe/QT [ Time Frame: Change in Tpe/QT after cigarette use ]
    interval indicative of ventricular repolarization measured on ECG

  3. Tpe/QTc [ Time Frame: Change in Tpe/QTc after cigarette use ]
    interval indicative of ventricular repolarization measured on ECG

  4. Total Cellular Reactive Oxygen Stress [ Time Frame: within 4 hours of cigarette use ]
    total cellular oxidative stress measured by flow cytometry


Secondary Outcome Measures :
  1. QT [ Time Frame: Change in QT after cigarette use ]
    interval indicative of ventricular repolarization measured on ECG

  2. QTc [ Time Frame: Change in QTc after cigarette use ]
    interval indicative of ventricular repolarization measured on ECG



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   21 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Chronic (> 1year) TCIG smoker HIV positive Stable ART Viral count non-detectable CD4 >500

Exclusion Criteria:

Known major illness (heart disease, diabetes, lung or liver disease) Daily recreational drug use, including cannabis >2 alcoholic drinks per day Obesity (>30 kg/m2) Recent (<3 months) infection


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04568395


Contacts
Layout table for location contacts
Contact: Holly Middlekauff, MD 310-206-6672 hmiddlekauff@mednet.ucla.edu
Contact: Isabelle Ruedisueli, BS 310-825-3510 iruedisueli@mednet.ucla.edu

Locations
Layout table for location information
United States, California
UCLA Recruiting
Los Angeles, California, United States, 890095
Contact: Izzy Ruedisueli, BS    310-825-3510    iruedisueli@mednet.ucla.edu   
Contact: Holly Middlekauff, MD    310-206-6672    hmiddlekauff@mednet.ucla.edu   
UCaliforniaLA Recruiting
Los Angeles, California, United States, 90095
Contact: Holly R Middlekauff, MD    310-206-6672    hmiddlekauff@mednet.ucla.edu   
Contact: Isabelle Ruedisueli, BS    310-825-3510    iruedisueli@mednet.ucla.edu   
Principal Investigator: Holly R Middlekauff, MD         
Sponsors and Collaborators
University of California, Los Angeles
Tobacco Related Disease Research Program
Layout table for additonal information
Responsible Party: Holly R Middlekauff, Principal Investigator, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT04568395    
Other Study ID Numbers: 20-001179
First Posted: September 29, 2020    Key Record Dates
Last Update Posted: October 8, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Inflammation
Tobacco Use Disorder
Pathologic Processes
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders